Hypothyroidism is a chronical disease with a bad influence on quality of life in this patients. Some researchers mean that self control in treatment and medication is a potential good development that can improve medical condition, make patients…
ID
Bron
Verkorte titel
Aandoening
Self-controlled dose
Levothyroxine
Quality of life
Hypothyroidism
Zelf-gecontroleerde dosis
Levothyroxine
Kwaliteit van leven
Hypothyreoidie
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
1. QoL by SF/RAND 36;<br>
2. Symptoms and complaints by symptomlist hypothyroidism;<br>
3. General symptom list and Hospital anxiety and depression scale;<br>
4. TSH,T4 and T3.
Achtergrond van het onderzoek
Background of the study:
Hypothyroidism is a chronical disease with a bad influence on quality of life in this patients. Some researchers mean that self control in treatment and medication is a potential good development that can improve medical condition, make patients stronger and can positively influence attitude and behaviour. Our hypothesis is that when patients can have influence on their dose of Levothyroxine, this will have a positive influence on their quality of life. It is also interesting what the role of placebo effect in this situation will be.
Objective of the study:
The goal of this study is to positively influence quality of life in patients with hypothyroidism by giving them back control in their treatment. We also want to see what the placebo effect will be. And at last we want to check if patients have the urge to lower their TSH levels if they can choose their own dose of Levothyroxine and if that has a relationship with their quality of life.
Study design:
A randomized, double blind, consecutive study on the outpatient clinic at the department of internal medicine and endocrinology of the Maasstad Hospital Rotterdam. Patients treated with Levothyroxine because of primary hypothyroidism will be included.
Study population:
Patients who visit the outpatient clinic of the department of internal medicine because of primary hypothyreoidism. There will have to be a state of euthyroidim and they have to use a stable dose of Levothyroxine for over more than 6 months without side effects.
Doel van het onderzoek
Hypothyroidism is a chronical disease with a bad influence on quality of life in this patients. Some researchers mean that self control in treatment and medication is a potential good development that can improve medical condition, make patients stronger and can positively influence attitude and behaviour. Our hypothesis is that when patients can have influence on their dose of Levothyroxine, this will have a positive influence on their quality of life. It is also interesting what the role of placebo effect in this situation will be.
Onderzoeksopzet
T = 0, 6, 12 and 18 months.
Onderzoeksproduct en/of interventie
Patients who are not content about the treatment of their hypothyroidism with Levothyroxine get the chance to controle their own dose. There will be 2 moments during the study where they can decide if they want to raise their dose of Levothyroxine. At the first time of choice randomization will follow and the first half of the group will get 25 mcg extra Levothyroxine and the other half will receive a placebo. After 6 weeks of treatment the placebo group will also receive 25 mcg extra medication. So after 12 weeks the whole group has been treated with 25 mcg extra Levohyroxine. At the second moment of choice patients can either go back to their original dose, stay at 25 mcg extra or decide they want another 25 mcg extra. There will be another randomization in group that wants extra medication. Half will get extra 25 mcg extra and half will get an placebo.
Publiek
C. Zevenbergen
Zwijndrecht 3331 RK
The Netherlands
+31 (0)10 2912716
ZevenbergenC@maasstadziekenhuis.nl
Wetenschappelijk
C. Zevenbergen
Zwijndrecht 3331 RK
The Netherlands
+31 (0)10 2912716
ZevenbergenC@maasstadziekenhuis.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. Primary Hypothyroidism;
2. Euthyroidism;
3. Stable dose of Levothyroxine for over 6 months;
4. Age 18-75;
5. Own wish to change dose of medication.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
Pregnancy.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
Register | ID |
---|---|
NTR-new | NL2675 |
NTR-old | NTR2803 |
CCMO | NL35082.101.11 |
ISRCTN | ISRCTN wordt niet meer aangevraagd. |
OMON | NL-OMON36807 |